Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013540005

FEI Number

3013540005

Entity Name

DIAMOND ORTHOPEDIC

City/State/Country

Gastonia, NC, US

Establishment Address

1669 Federal Ave, Gastonia, NC 28052, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Diamond Orthopedic (Owner Number: 10054574)

Owner / Operator Contact Address

1669 Federal Ave, Gastonia, NC 28052, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Diamond Orthopedic Forceps Diamond Orthopedic Bone Tap Diamond Orthopedic Manual Surgical Instrument Diamond Orthopedic Countersink Fully Threaded Tapered Headless Compression Diamond Orthopedic Screwdriver Diamond Orthopedic Washer Diamond Orthopedic Drill Bit Diamond Orthopedic Pin Diamond Orthopedic Surgical Tray Diamond Orthopedics Wire Cutter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2019-03-22
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2017-04-04
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2017-04-04
HWW	Countersink	Orthopedic	Class 1	888.4540	2017-04-04
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2023-12-27
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2023-12-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-12-27
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2017-04-04
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2024-07-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-07-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-07-29
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2017-04-04
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2019-03-22
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2019-03-22
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2017-04-04
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2017-04-04

Official Correspondent

Roy Bivens

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Diamond Orthopedic

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K895079	Buckman Co., Inc.	ACE BEADED K-WIRES ACE OLIVE WIRES	1989-09-13
K922193	Osteo AG	OSTEO KIRSCHNER WIRE	1992-07-23
K850026	Kirkstil Corp., Inc.	ORTHOPEDIC IMPLANT NAILS & PINS	1985-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013540005. Last updated year: 2026. Please use registration number 3013540005 when referencing this establishment in official correspondence.